CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled trial, which aims to assess the safety and efficacy of treatment with convalescent plasma for patients with moderate-severe COVID-19. Participants will be randomized 2:1 to two parallel treatment arms: Convalescent plasma, and intravenous placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.
The study is a randomized, double blinded, placebo-controlled, multicenter study with two
parallel treatment arms consisting of either convalescent plasma or intravenous placebo. We
plan to enroll a total of 1100 patients yielding a statistical power of 80 % to show a 30%
relative reduction in risk of mechanical ventilation or death at day 28. Patients with
confirmed COVID-19 infection and signs compatible with pneumonia will be enrolled in the
study. The participants will be randomized 2:1 to the parallel treatment arms, and receive
either single dose infusion treatment.
The primary outcome is a composite endpoint of all-cause mortality or need of invasive
mechanical ventilation up to 28 days. Interim analysis will be performed frequently.
As new knowledge of treatment options for COVID-19 have emerged, the treatment arms including
sarilumab, baricitininb, hydroxychloroquine and oral placebo have been terminated.
Biological: Convalescent anti-SARS-CoV-2 plasma
Single infusion of convalescent anti-SARS-CoV-2 plasma (2 x 300 mL)
Other Name: Convalescent plasma
Other: Infusion placebo
Saline 0.9% (600 ml) as an iv single dose infusion
Inclusion Criteria:
- ≥18 years of age
- Confirmed COVID-19 infection by presence of SARS-CoV-2 nucleic acid by polymerase
chain reaction (PCR)
- Evidence of pneumonia given by at least one of the following: SpO2 ≤93% on ambient air
or PaO2/FiO2 <300 mmHg/40 kPa OR Radiographic findings compatible with COVID-19
pneumonia
- For women of childbearing potential: Negative pregnancy test and willingness to use
contraceptive (consistent with local regulations) during study period
- Signed Informed Consent Form by any patient capable of giving consent, or, when the
patient is not capable of giving consent, by his or her legal/authorized
representatives
Exclusion Criteria:
- In the opinion of the investigator, progression to death is imminent and inevitable
within the next 24 hours, irrespective of the provision of treatment
- Participating in other drug clinical trials (participation in COVID-19 antiviral
trials may be permitted if approved by sponsor)*
- Pregnant or breastfeeding, positive pregnancy test in a pre-dose examination
- Any serious medical condition or abnormality of clinical laboratory tests that, in the
investigator's judgment, precludes the patient's safe participation in and completion
of the study
Aalborg University Hospital
Aalborg, Denmark
Aarhus University Hospital
Arhus, Denmark
Bispebjerg Hospital
Copenhagen, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev Gentofte Hospital
Herlev, Denmark
Herning Hospital
Herning, Denmark
Nordsjællands Hospital
Hillerød, Denmark
Hvidovre Hospital
Hvidovre, Denmark
Kolding Hospital
Kolding, Denmark
Odense University Hospital
Odense, Denmark
Roskilde Hospital
Roskilde, Denmark
Vejle Hospital
Vejle, Denmark